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October 4, 2022 — Lexicon Pharmaceuticals, Inc. announced that a new analysis of results from the SOLOIST-WHF Phase 3outcomes trial of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, was presented at the Heart Failure Society of America (HSFA) Annual Scientific Meeting 2022.
The new analysis was presented by Bertram Pitt, M.D., FACC, professor of medicine emeritus at the University of Michigan, School of Medicine, and co-chair for the SOLOIST-WHF trial as well as a member of the Executive Committee for the Phase 3 SCORED trial of sotagliflozin. The poster, entitled “Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, Reduces First and Subsequent Heart Failure-related Events in Patients Admitted for Worsening Heart Failure”, was presented on Sunday, October 2nd during the general poster viewing session IV (https://hfsa.org/hfsa-annual-scientific-meeting-2022).
“Patients treated with sotagliflozin in the SOLOIST-WHF trial experienced fewer single as well as multiple heart failure events than those receiving placebo,” said Dr. Pitt. “Thus, we conclude that sotagliflozin altered the trajectory of patients hospitalized for worsening heart failure by reducing early and recurrent heart failure events.”
“We are pleased that data from the SOLOIST-WHF trial continues to yield robust findings that further help characterize and differentiate the potential benefits of sotagliflozin in heart failure,” said Dr. Craig Granowitz, Lexicon’s senior vice president and chief medical officer.
About the SCORED and SOLOIST-WHF Studies
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo. Key secondary endpoints included total number of events of deaths from cardiovascular causes, non-fatal myocardial infarction, and non-fatal stroke.
SOLOIST-WHF was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
Both SCORED and SOLOIST-WHF achieved their respective primary endpoints, with overall tolerability similar to placebo across both trials. Results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease” and “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” which may be accessed at www.nejm.org.
June 11, 2025 
